Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS (dal-GenE)

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: dalcetrapib; Drug: Placebo

Detailed Description

This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype. The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

• Study Type: Interventional
• Enrollment (Actual): 6147
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Bahía Blanca, Argentina
    • Research Site
  • Ciudad Autonoma de Buenos Aires, Argentina
    • Research Site
  • Cordoba, Argentina
    • Research Site
  • Coronel Suarez, Argentina
    • Research Site
  • Corrientes, Argentina
    • Research Site
  • Esperanza, Argentina
    • Research Site
  • Junin, Argentina
    • Research Site
  • La Plata, Argentina
    • Research Site
  • Mar del Plata, Argentina
    • Research Site
  • Mendoza, Argentina
    • Research Site
  • Moron, Argentina
    • Research Site
  • Quilmes, Argentina
    • Research Site
  • Rosario, Argentina
    • Research Site
  • San Juan, Argentina
    • Research Site
  • San Luis, Argentina
    • Research Site
  • San Martin, Argentina
    • Research Site
  • San Miguel de Tucuman, Argentina
    • Research Site
  • San Nicolas, Argentina
    • Research Site
  • Santa Fe, Argentina
    • Research Site
  • Santa Rosa, Argentina
    • Research Site
  • Tucuman, Argentina
    • Research Site
  • Venado Tuerto, Argentina
    • Research Site
  • Vicente Lopez, Argentina
    • Research Site
  • Villa Allende, Argentina
    • Research Site
  • Villa Maria, Argentina
    • Research Site
• Australia
  • New South Wales
    • Bruce, New South Wales, Australia
      • Research Site
    • Gosford, New South Wales, Australia
      • Research Site
    • Liverpool, New South Wales, Australia
      • Research Site
    • Saint Leonards, New South Wales, Australia
      • Research Site
  • Queensland
    • Cairns, Queensland, Australia
      • Research Site
    • Chermside, Queensland, Australia
      • Research Site
    • Douglas, Queensland, Australia
      • Research Site
    • Herston, Queensland, Australia
      • Research Site
    • Milton, Queensland, Australia
      • Research Site
    • Redcliffe, Queensland, Australia
      • Research Site
    • Woolloongabba, Queensland, Australia
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia
      • Research Site
    • Elizabeth Vale, South Australia, Australia
      • Research Site
    • Woodville South, South Australia, Australia
      • Research Site
  • Tasmania
    • Hobart, Tasmania, Australia
      • Research Site
  • Victoria
    • Epping, Victoria, Australia
      • Research Site
    • Geelong, Victoria, Australia
      • Research Site
    • Melbourne, Victoria, Australia
      • Research Site
  • Western Australia
    • Joondalup, Western Australia, Australia
      • Research Site
    • Murdoch, Western Australia, Australia
      • Research Site
    • Nedlands, Western Australia, Australia
      • Research Site
    • Perth, Western Australia, Australia
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• Austria
  • Braunau Am Inn, Austria
    • Research Site
  • Feldkirch, Austria
    • Research Site
  • Krems, Austria
    • Research Site
  • Linz, Austria
    • Research Site
  • Vienna, Austria
    • Research Site
  • Wien, Austria
    • Research Site
  • Wiener Neustadt, Austria
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• Belgium
  • Aalst, Belgium
    • Research Site
  • Bonheiden, Belgium
    • Research Site
  • Brussels, Belgium
    • Research Site
  • Genk, Belgium
    • Research Site
  • Liege, Belgium
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  • Maaseik, Belgium
    • Research Site
  • Mechelen, Belgium
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  • Ottignies, Belgium
    • Research Site
  • Sint-Niklaas, Belgium
    • Research Site
• Brazil
  • Belo Horizonte, Brazil
    • Research Site
  • Blumenau, Brazil
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  • Brasilia, Brazil
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  • Campina Grande do Sul, Brazil
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  • Campinas, Brazil
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  • Campo Grande, Brazil
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  • Curitiba, Brazil
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  • Fortaleza, Brazil
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  • Goiania, Brazil
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  • Marilia, Brazil
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  • Maringa, Brazil
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  • Natal, Brazil
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  • Porto Alegre, Brazil
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  • Recife, Brazil
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  • Ribeirao Preto, Brazil
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  • Salvador, Brazil
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  • Santo André, Brazil
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  • Sao Jose do Rio Preto, Brazil
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  • Sao Paulo, Brazil
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  • Uberlandia, Brazil
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  • Vitoria, Brazil
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• Bulgaria
  • Blagoevgrad, Bulgaria
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  • Dimitrovgrad, Bulgaria
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  • Haskovo, Bulgaria
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  • Pazardzhik, Bulgaria
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  • Pernik, Bulgaria
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  • Pleven, Bulgaria
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  • Plovdiv, Bulgaria
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  • Sandanski, Bulgaria
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  • Sofia, Bulgaria
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• Canada
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  • Alberta
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  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
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  • Nova Scotia
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  • Ontario
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  • Quebec
    • Chicoutimi, Quebec, Canada
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    • Levis, Quebec, Canada
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    • Longueuil, Quebec, Canada
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    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montréal
    • Montreal, Quebec, Canada
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    • Sherbrooke, Quebec, Canada
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• Chile
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• Czechia
  • Bilina, Czechia
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  • Prague 6, Czechia
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  • Slany, Czechia
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  • Trutnov, Czechia
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  • Zlin, Czechia
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• Denmark
  • Aalborg, Denmark
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  • Frederiksberg, Denmark
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  • Glostrup, Denmark
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  • Hellerup, Denmark
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  • Herning, Denmark
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  • Hillerod, Denmark
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  • Kobenhavn, Denmark
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  • Naestved, Denmark
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  • Silkeborg, Denmark
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• Finland
  • Jyvaskyla, Finland
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  • Oulu, Finland
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  • Pori, Finland
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  • Turku, Finland
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• France
  • Besancon, France
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  • Bron, France
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  • Clermont-Ferrand, France
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  • Corbeil-Essonnes, France
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  • Dijon, France
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  • Limoges, France
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  • Lyon, France
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  • Montpellier, France
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  • Pessac, France
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  • Poitiers, France
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  • Toulouse, France
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  • Tourcoing, France
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  • Valenciennes, France
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• Germany
  • Aachen, Germany
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  • Berlin, Germany
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  • Bochum, Germany
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  • Bremen, Germany
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  • Chemnitz, Germany
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  • Coburg, Germany
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  • Dresden, Germany
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  • Erfurt, Germany
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  • Fuerth, Germany
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  • Heidelberg, Germany
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  • Leipzig, Germany
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  • Mainz, Germany
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  • Monchengladbach, Germany
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  • Munich, Germany
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• Hungary
  • Baja, Hungary
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  • Eger, Hungary
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  • Kecskemet, Hungary
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  • Miskolc, Hungary
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  • Nyiregyhaza, Hungary
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  • Pecs, Hungary
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  • Szekesfehervar, Hungary
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  • Szombathely, Hungary
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  • Zalaegerszeg, Hungary
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• Israel
  • Afula, Israel
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  • Ashkelon, Israel
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  • Beer Sheva, Israel
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  • Bnei Brak, Israel
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  • Haifa, Israel
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  • Holon, Israel
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  • Jerusalem, Israel
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  • Kfar Saba, Israel
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  • Nahariya, Israel
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  • Nazareth, Israel
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  • Petach-Tikva, Israel
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  • Poriyya 'Illit, Israel
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  • Rehovot, Israel
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  • Safed, Israel
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  • Tel Aviv, Israel
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  • Tel Hashomer, Israel
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  • Zerifin, Israel
    • Research Site
• Italy
  • Ancona, Italy
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  • Ascoli Piceno, Italy
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  • Cagliari, Italy
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  • Casarano, Italy
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  • Cortona, Italy
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  • Empoli, Italy
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  • Firenze, Italy
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  • Foggia, Italy
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  • Giugliano in Campania, Italy
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  • Gubbio, Italy
    • Research Site
  • Milano, Italy
    • Research Site
  • Napoli, Italy
    • Research Site
  • Novara, Italy
    • Research Site
  • Roma, Italy
    • Research Site
  • Rozzano, Italy
    • Research Site
  • Sanremo, Italy
    • Research Site
  • Saronno, Italy
    • Research Site
  • Scorrano, Italy
    • Research Site
  • Seriate, Italy
    • Research Site
  • Torino, Italy
    • Research Site
  • Treviglio, Italy
    • Research Site
• Netherlands
  • 's-Hertogenbosch, Netherlands
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  • Amsterdam, Netherlands
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  • Arnhem, Netherlands
    • Research Site
  • Capelle Aan Den IJssel, Netherlands
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  • Den Haag, Netherlands
    • Research Site
  • Deventer, Netherlands
    • Research Site
  • Doetinchem, Netherlands
    • Research Site
  • Ede, Netherlands
    • Research Site
  • Goes, Netherlands
    • Research Site
  • Gouda, Netherlands
    • Research Site
  • Hoogeveen, Netherlands
    • Research Site
  • Hoorn, Netherlands
    • Research Site
  • Leeuwarden, Netherlands
    • Research Site
  • Leiden, Netherlands
    • Research Site
  • Rotterdam, Netherlands
    • Research Site
  • Schiedam, Netherlands
    • Research Site
  • Sneek, Netherlands
    • Research Site
  • Tiel, Netherlands
    • Research Site
  • Tilburg, Netherlands
    • Research Site
  • Uden, Netherlands
    • Research Site
  • Veldhoven, Netherlands
    • Research Site
  • Venlo, Netherlands
    • Research Site
  • Zaandam, Netherlands
    • Research Site
  • Zutphen, Netherlands
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• New Zealand
  • Christchurch, New Zealand
    • Research Site
  • Dunedin, New Zealand
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  • Grafton, New Zealand
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  • Hamilton, New Zealand
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  • Hastings, New Zealand
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  • Lower Hutt, New Zealand
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  • Nelson, New Zealand
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  • New Plymouth, New Zealand
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  • Rotorua, New Zealand
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• Poland
  • Bydgoszcz, Poland
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  • Elblag, Poland
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  • Gdynia, Poland
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  • Krakow, Poland
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  • Lodz, Poland
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  • Zabrze, Poland
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• Portugal
  • Almada, Portugal
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  • Faro, Portugal
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  • Leiria, Portugal
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  • Lisboa, Portugal
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  • Senhora da Hora, Portugal
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  • Setubal, Portugal
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• Puerto Rico
  • Bayamon, Puerto Rico
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  • Caguas, Puerto Rico
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• Romania
  • Arad, Romania
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  • Baia Mare, Romania
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  • Bucharest, Romania
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• Russian Federation
  • Arkhangelsk, Russian Federation
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  • Barnaul, Russian Federation
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  • Ekaterinburg, Russian Federation
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  • Irkutsk, Russian Federation
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• Slovakia
  • Bardejov, Slovakia
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• South Africa
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• Spain
  • A Coruna, Spain
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  • Lleida, Spain
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• Sweden
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• Switzerland
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• Turkey
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• United Arab Emirates
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• United Kingdom
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• United States
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      • Research Site
  • Iowa
    • West Des Moines, Iowa, United States
      • Research Site
  • Kansas
    • Wichita, Kansas, United States
      • Research Site
  • Kentucky
    • Owensboro, Kentucky, United States
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States
      • Research Site
    • Covington, Louisiana, United States
      • Research Site
  • Maine
    • Bangor, Maine, United States
      • Research Site
    • Biddeford, Maine, United States
      • Research Site
    • Lewiston, Maine, United States
      • Research Site
  • Maryland
    • Annapolis, Maryland, United States
      • Research Site
    • Baltimore, Maryland, United States
      • Research Site
    • Bethesda, Maryland, United States
      • Research Site
    • Columbia, Maryland, United States
      • Research Site
    • Salisbury, Maryland, United States
      • Research Site
  • Massachusetts
    • Hyannis, Massachusetts, United States
      • Research Site
  • Michigan
    • Alpena, Michigan, United States
      • Research Site
    • Bay City, Michigan, United States
      • Research Site
    • Lansing, Michigan, United States
      • Research Site
    • Midland, Michigan, United States
      • Research Site
    • Mount Clemens, Michigan, United States
      • Research Site
    • Muskegon, Michigan, United States
      • Research Site
    • Saginaw, Michigan, United States
      • Research Site
    • Saint Joseph, Michigan, United States
      • Research Site
    • Ypsilanti, Michigan, United States
      • Research Site
  • Minnesota
    • Coon Rapids, Minnesota, United States
      • Research Site
    • Duluth, Minnesota, United States
      • Research Site
    • Minneapolis, Minnesota, United States
      • Research Site
    • Saint Cloud, Minnesota, United States
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States
      • Research Site
    • Washington, Missouri, United States
      • Research Site
  • Montana
    • Missoula, Montana, United States
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States
      • Research Site
  • New Jersey
    • Bridgewater, New Jersey, United States
      • Research Site
    • Linden, New Jersey, United States
      • Research Site
    • Somerset, New Jersey, United States
      • Research Site
    • Summit, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
  • New York
    • Buffalo, New York, United States
      • Research Site
    • Johnson City, New York, United States
      • Research Site
    • New Windsor, New York, United States
      • Research Site
    • New York, New York, United States
      • Research Site
    • Poughkeepsie, New York, United States
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States
      • Research Site
    • Greensboro, North Carolina, United States
      • Research Site
    • Pinehurst, North Carolina, United States
      • Research Site
    • Rocky Mount, North Carolina, United States
      • Research Site
    • Wilmington, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
      • Research Site
  • North Dakota
    • Minot, North Dakota, United States
      • Research Site
  • Ohio
    • Canton, Ohio, United States
      • Research Site
    • Cincinnati, Ohio, United States
      • Research Site
    • Columbus, Ohio, United States
      • Research Site
    • Springfield, Ohio, United States
      • Research Site
    • Toledo, Ohio, United States
      • Research Site
    • Zanesville, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Pennsylvania
    • Butler, Pennsylvania, United States
      • Research Site
    • Chambersburg, Pennsylvania, United States
      • Research Site
    • Erie, Pennsylvania, United States
      • Research Site
    • Hershey, Pennsylvania, United States
      • Research Site
    • Langhorne, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
    • Wyomissing, Pennsylvania, United States
      • Research Site
    • York, Pennsylvania, United States
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States
      • Research Site
  • South Carolina
    • Spartanburg, South Carolina, United States
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States
      • Research Site
  • Tennessee
    • Greeneville, Tennessee, United States
      • Research Site
    • Jackson, Tennessee, United States
      • Research Site
    • Oak Ridge, Tennessee, United States
      • Research Site
  • Texas
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site
    • Kingwood, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site
    • Victoria, Texas, United States
      • Research Site
    • Wichita Falls, Texas, United States
      • Research Site
  • Utah
    • Layton, Utah, United States
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States
      • Research Site
    • Norfolk, Virginia, United States
      • Research Site
    • Virginia Beach, Virginia, United States
      • Research Site
    • Winchester, Virginia, United States
      • Research Site
  • Washington
    • Seattle, Washington, United States
      • Research Site
  • Wisconsin
    • La Crosse, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
• AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
• Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).

Exclusion Criteria:

• Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one method of contraception*
• New York Heart Association (NYHA) Class III or IV heart failure
• Last known hemoglobin <10 g/dL
• Index ACS event presumed due to uncontrolled hypertension

(*) Varies by region

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dalcetrapib; Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	Drug: dalcetrapib; Cholesterol Ester Transfer Protein inhibitor
Placebo Comparator: Placebo; Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Drug: Placebo; matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke	All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke, as positively adjudicated by the CEC.	From randomization to the first occurrence of any component of the composite primary endpoint (median duration of follow-up was 39.9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization	All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The primary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite endpoint, which included death from cardiovascular causes, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute coronary syndrome (with electrocardiogram abnormalities) or unanticipated coronary revascularization, as positively adjudicated by the CEC.	From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure	All efficacy endpoints were adjudicated by an independent clinical endpoint committee (CEC). The secondary efficacy endpoint was the time from randomization to the first occurrence of any component of the composite secondary endpoint, which included death from cardiovascular causes, cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for new or worsening heart failure, as positively adjudicated by the CEC.	From randomization to the first occurrence of any component of the composite secondary endpoint (median duration of follow-up was 39.9 months)

Collaborators and Investigators

• Sponsor: DalCor Pharmaceuticals
• Collaborators: Medpace, Inc.; The Montreal Health Innovations Coordinating Center (MHICC); Roche Molecular Systems, Inc
• Investigators: Study Director: Donald M Black, MD, DalCor Pharmaceuticals

Publications and helpful links

General Publications

• Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Gregoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dube MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374. Erratum In: Eur Heart J. 2022 Sep 20;:
• Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093. Review.
• Tardif JC, Dube MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Dalcetrapib
• Other Study ID Numbers: DAL-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No